BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    E-LINK Software (Version 16)

    DI: 05060481690454 · Model: 16xx-xxx-xxxx · BIOMETRICS LIMITED
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    E-LINK Software (Version 16)
    Primary DI
    05060481690454
    Version / Model
    16xx-xxx-xxxx
    Company Name
    BIOMETRICS LIMITED
    Labeler DUNS
    519969810
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-09
    Public Version
    2
    Public Version Date
    2024-02-05
    Public Version Status
    Update
    Public Device Record Key
    e96f4693-f2bb-49a7-81e9-792b8fb02b5d

    Device Description

    E-LINK is a computerized modular system bringing both evaluation and exercise together in an exciting format with an extensive scope of clinical applications for the upper and lower extremities. E-LINK is available in English, Chinese, German and Spanish.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ISD Exerciser, Measuring
    BXB Exerciser, Powered
    ION Exerciser, Non-Measuring

    GMDN Terms

    Code Name
    47518 Biomechanical function analysis/rehabilitation software

    Identifiers

    Type ID
    Primary 05060481690454